Indocyanine Green Fluorescence Imaging in Prevention of Colorectal Anastomotic Leakage (ICG-COLORAL)

This is a randomized, controlled, parallel, multicenter trial to determine the difference in post-operative anastomotic leakages in colorectal surgery, where anastomosis perfusion is evaluated using indocyanine green fluorescence imaging as an addition to standard surgical practice compared to surgical practice alone.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Neoplasms; Colorectal Neoplasms; Colorectal Cancer; Gastrointestinal Cancer; Diverticulosis, Colonic; Gastrointestinal Disease
• Intervention / Treatment: Device: ICG fluorescence imaging

• Study Type: Interventional
• Enrollment (Anticipated): 1062
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jyrki Kössi, MD, PhD; Phone Number: +358381911; Email: jyrki.kossi@phhyky.fi
• Study Contact Backup: Name: Olli Helminen, MD, PhD; Phone Number: +358142691811; Email: olli.helminen@oulu.fi

Study Locations

• Finland
  • Jyväskylä, Finland
    • Recruiting
    • Central Finland Central Hospital
    • Contact: Olli Helminen, MD, PhD; Email: olli.helminen@oulu.fi
  • Lahti, Finland
    • Recruiting
    • Päijät Häme Central Hospital
    • Contact: Jyrki Kössi, MD, PhD; Email: jyrki.kossi@phhyky.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All consenting patients in the catchment area of participating hospitals who undergo elective colorectal surgery with planned primary anastomosis are eligible for this study.
• Of rectal cancer patients only those with pathology in the proximal third will be included in the study (defined by area proximal from peritoneal fold).

Exclusion Criteria:

• Emergent patients
• Patients with proven diverticular abscess and colonic fistulas are excluded
• Patients with planned open surgery are excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ICG fluorescence imaging; Colorectal surgery and anastomosis will be performed according to standard practice with the addition of intraoperative indocyanine green fluorescence imaging.	Device: ICG fluorescence imaging; The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.
No Intervention: Standard procedure; Standard colorectal surgery and anastomosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Anastomosis leakage rate	0 to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of anastomosis leakage	Grade A-C according to International Study Group of Rectal Cancer	0 to 90 days
Timing of anastomosis leakage	Days	0 to 90 days
Deep surgical site infections	Yes/no	0 to 90 days
Hospital readmission rate		0 to 90 days
Reoperation rate		0 to 90 days
30- and 90-day complications according to Clavien-Dindo Classification	Clavien-Dindo Score from Grade 0 (no complications) to Grade V (Death of a patient). Five grades and additionally Grade III and IV will be divided to a and b.	0 to 90 days
Operation time	Time from the start of the operation until the surgeon has ended the operation	0-600 minutes
Length of hospital stay	Day of the operation is considered the day 0	0-365 days
30- and 90-day mortality		0 to 90 days
Time to first bowel movement	Postoperative day when the first bowel movement occurs	0-30 days
Time to first flatus	Postoperative day when the first flatus occurs	0-30 days
Hospital costs		0 to 90 days

Collaborators and Investigators

• Sponsor: Oulu University Hospital
• Collaborators: Turku University Hospital; Tampere University Hospital; University of Oulu; Päijänne Tavastia Central Hospital; Central Finland Hospital District; Hospital District of Helsinki and Uusimaa; Seinäjoki Central Hospital, Seinäjoki, Finland
• Investigators: Principal Investigator: Jyrki Kössi, MD, PhD, Päijänne Tavastia Central Hospital; Principal Investigator: Olli Helminen, MD, PhD, Oulu University Hospital, Oulu, Finland and Central Finland Central Hospital, Jyväskylä, Finland; Principal Investigator: Heikki Huhta, MD, PhD, Oulu University Hospital; Principal Investigator: Juha Rinne, MD, Päijänne Tavastia Central Hospital; Principal Investigator: Matti Kairaluoma, MD, PhD, Central Finland Central Hospital, Jyväskylä, Finland; Principal Investigator: Tero Rautio, MD, PhD, Oulu University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2018
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: March 25, 2018
• First Submitted That Met QC Criteria: July 17, 2018
• First Posted (Actual): July 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2023
• Last Update Submitted That Met QC Criteria: March 24, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Colorectal surgery; Anastomosis; Fluorescence imaging; Anastomosis leak
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Postoperative Complications; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Rectal Diseases; Diverticular Diseases; Neoplasms; Colorectal Neoplasms; Gastrointestinal Diseases; Digestive System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Anastomotic Leak; Diverticulum; Diverticulosis, Colonic
• Other Study ID Numbers: ICG-COLORAL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No